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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04265599




Registration number
NCT04265599
Ethics application status
Date submitted
7/02/2020
Date registered
11/02/2020

Titles & IDs
Public title
Exploring Pathogenesis and Treatment of Hypercalcemia Caused by Intramuscular Injection of Paraffinoil
Scientific title
Hypercalcemia After Cosmetic Paraffin Oil Injections: Unravelling Etiology, Pathogenesis and Potential Treatments
Secondary ID [1] 0 0
VEK RegionH: H-19010297
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hypercalcemia 0 0
Renal Injury 0 0
Paraffinoma 0 0
Condition category
Condition code

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of patients with concentration of ionized calcium in plasma above normal range = Hypercalcemia
Timepoint [1] 0 0
at first examination or developed during observation period until 2025
Primary outcome [2] 0 0
Number of patients with concentration of parathyroid hormone PTH in plasma below normal range
Timepoint [2] 0 0
at first examination or developed during observation period until 2025

Eligibility
Key inclusion criteria
* previous intramuscular injection of paraffin or other oil
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* none

Study design
Purpose
Duration
Selection
Timing
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
30/04/2019
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
31/01/2027
Actual
Sample size
Target
200
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
Denmark
State/province [1] 0 0
Copenhagen

Funding & Sponsors
Primary sponsor type
Other
Name
Herlev Hospital
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Ebbe Eldrup, DMSc
Address 0 0
Country 0 0
Phone 0 0
800-045-3868
Fax 0 0
Email 0 0
ebbe.eldrup@regionh.dk
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT04265599